Abstract:

Disclosed is an electrochemical biosensor measuring device which can be
used together with an electrochemical biosensor. The biosensor measuring
device comprises an electrical connection portion which is electrically
connected with the electrodes of the biosensor upon the insertion of the
biosensor there into, and a connector having a structure in which at
least one light absorption or reflection path sequentially comprising a
light emitter-production lot information identification portion-detector
unit is provided to identify the production lot information recorded in
the biosensor. The electrochemical biosensor measuring device can
automatically identify the production lot information of the biosensor,
encoded in the form of a hue or hole marks, upon the insertion of the
electrochemical biosensor into the measuring device, thereby obviating
the need to manually input the production lot information of the
biosensor. Thus, inconvenience and the frequency of errors, which occur
when a user personally inputs the production lot information, can be
reduced, with the result that the measured values can be conveniently and
accurately acquired.

Claims:

1. An electrochemical biosensor measuring device, which measures an
electrochemical biosensor composed of plurality of electrodes including
at least a working electrode and an auxiliary electrode prepared on at
least one or two insulating plates; a capillary sample cell for
introducing a sample into the electrodes; a reaction reagent layer,
formed on the working electrode, containing a redox enzyme and an
electron transfer mediator; an electrical connection portion for
connecting the working electrode and the auxiliary electrode; and a
production lot information identification portion configured such that
production lot information is recorded on at least one insulating plate,
which is selected from among at least two planar insulating plates and
does not interrupt a connection between the electrodes, wherein the
biosensor measuring device comprises a connector having a structure in
which at least one light absorption or reflection path sequentially
comprising a light emitter-production lot information identification
portion-detector unit is provided to identify the production lot
information recorded in the biosensor.

2. The electrochemical biosensor measuring device according to claim 1,
wherein the plurality of electrodes include a sample fluidity determining
electrode.

3. The electrochemical biosensor measuring device according to claim 1,
wherein the production lot information identification portion includes at
least one mark selected from a group consisting of a hue mark, a hole
mark and a light-transmitting film-covered hole mark.

4. The electrochemical biosensor measuring device according to claim 3,
wherein the production lot information identification portion includes
one or more hue marks displaying the information about differences
between production lots by differences in the color, brightness, or
chroma of a plurality of color images.

5. The electrochemical biosensor measuring device according to claim 3,
wherein the production lot information identification portion includes
one or more hole marks displaying the information about differences
between production lots by differences in the combination of a plurality
of open and closed holes.

6. The electrochemical biosensor measuring device according to claim 3,
wherein the production lot information identification portion includes
one or more light-transmitting film covered hole marks displaying the
information about differences between production lots by differences in
the degree of transmission of light through the light-transmitting films
covering a plurality of holes.

7. The electrochemical biosensor measuring device according to claim 4,
wherein the number of the hue marks ranges from 1 to 10.

9. The electrochemical biosensor measuring device according to claim 1,
wherein the light emitter is an infrared light source.

10. The electrochemical biosensor measuring device according to claim 1,
wherein the detector is an optical identification device which identifies
the production lot information by discerning differences in the color,
brightness or chroma of the hue marks, hole marks or light-transmitting
film-covered hole marks of the production lot information identification
portion.

11. The electrochemical biosensor measuring device according to claim 1,
wherein the detector is an image signal identification device which
identifies the production lot information by discerning differences in
the image signal of the hue mark of the production lot information
identification portion.

12. The electrochemical biosensor measuring device according to claim 1,
wherein the light emitters and the detectors are constructed in a
separate or integrated structure.

13. The electrochemical biosensor measuring device according to claim 1,
wherein the connector has a body made of a transparent material.

14. The electrochemical biosensor measuring device according to claim 1,
wherein the connector is provided with a transmission window in one side
thereof so that light absorbed or reflected via the light
emitter-production lot information identification portion-detector are
passed there through.

15. The electrochemical biosensor measuring device according to claim 1,
wherein the connector is provided with a sliding door structure in one
side thereof so that the light beams absorbed or reflected via the light
emitter-production lot information identification portion-detector system
pass through the connector.

16. The electrochemical biosensor measuring device according to claim 15,
wherein the sliding door structure is connected to a device that can
passively or automatically remove the biosensor.

17. The electrochemical biosensor measuring device according to claim 1,
wherein the connector includes the light emitters, the detector and the
electrical connection portion in an integrated structure within the body
thereof.

18. A measuring method using a biosensor measuring device,
comprising:inserting a biosensor into the connector port of the measuring
device to activate its power (step 1);identifying the production lot
information of the biosensor inserted at Step 1 (step 2);activating the
measurement and operation processes of the biosensor measuring device in
conformity with the production lot information identified at Step 2 (step
3); andintroducing a liquid sample to the sample inlet of the biosensor
to result in quantitative electrochemical information about the sample,
quantifying a specific component of the liquid sample, and displaying
quantification results (step 4).

19. The measuring method according to claim 18, wherein the identifying
step is carried out by detecting at least one mark selected from a group
consisting of a hue mark, a hole mark and a light-transmitting
film-covered hole mark.

20. The measuring method according to claim 19, wherein the hue mark
displays information about differences between production lots by
differences in the color, brightness, or chroma of a plurality of color
images.

21. The measuring method according to claim 19, wherein the hole mark
displays information about differences between production lots by
differences in the combination of a plurality of holes which are
independently open or closed.

22. The measuring method according to claim 19, wherein the
light-transmitting-covered hole mark displays information about
differences between production lots by differences in the degree of
transmission of light through a plurality of light-transmitting films
covering corresponding open holes.

23. The measuring method according to claim 20, wherein the number of the
hue marks ranges from 1 to 10.

24. The measuring method according to claim 18, wherein the identifying
step is carried out by applying light from three-component photodiodes
that emit red, green and blue colors or four-components photodiodes that
emit white, red, green and blue colors to a hue mark, a hole mark or a
light-transmitting film-covered hole mark of a production lot information
identification portion, and detecting a variation or difference in the
wavelength, color, brightness or chroma of the light according to
reflection from or transmission through the mark using an optical
identification device.

25. The measuring method according to claim 18, wherein the identifying
step is carried out by applying light from one or more infrared light
sources capable of emitting infrared light to a hue mark, a hole mark or
a light-transmitting film-covered hole mark of a production lot
information identification portion, and detecting a variation or
difference in the wavelength, color, brightness or chroma of the light
according to the reflection from or the transmission through the mark
using one or more optical identification devices.

26. The measuring method according to claim 18, wherein the identifying
step is carried out by detecting an image signal from a hue mark of a
production lot information identification portion with an image signal
identification device and analyzing the information encoded by the image
signal.

27. The electrochemical biosensor measuring device according to claim 5,
wherein the number of the hole marks ranges from 1 to 10.

28. The electrochemical biosensor measuring device according to claim 6,
wherein the number of the hole marks ranges from 1 to 10.

29. The measuring method according to claim 21, wherein the number of the
hole marks ranges from 1 to 10.

30. The measuring method according to claim 22, wherein the number of the
hole marks ranges from 1 to 10.

Description:

[0002]For the diagnosis and prophylaxis of diabetes mellitus, the
importance of periodically monitoring blood glucose levels is
increasingly emphasized. Nowadays, strip-type biosensors designed to be
used in hand-held reading devices allow individuals to readily monitor
glucose levels in the blood.

[0003]Many various commercialized biosensors measure the blood glucose
content of blood samples using an electrochemical technique. The
principle of the electrochemical technique is based on the following
Reaction 1.

Glucose+GOx-FAD→gluconic acid+GOx-FADH2

GOx-FADH2+Mox→GOx-FAD+Mred [Reaction 1]

[0004]wherein, GOx represents glucose oxidase; GOx-FAD and GOx-FADH2
respectively represent an oxidized and a reduced state of
glucose-associated FAD (flavin adenine dinucleotide), a cofactor required
for the catalysis of glucose oxidase; and Mox and Mred denote the
oxidized and reduced states, respectively, of an electron transfer
mediator.

[0006]The principle by which blood glucose is measured using the biosensor
is as follows.

[0007]Glucose in the blood is oxidized to gluconic acid by the catalytic
activity of glucose oxidase, with the cofactor FAD reduced to FADH2.
Then, the reduced cofactor FADH2 transfers electrons to the mediator, so
that FADH2 returns to its oxidized state; that is, FAD and the
mediator are reduced. The reduced mediator is diffused to the surface of
the electrodes. The series of reaction cycles is driven by the anodic
potential applied at the working electrode, and redox current
proportional to the level of glucose is measured. Compared to biosensors
based on colorimetry, electrochemical biosensors (that is, based on
electrochemistry) have the advantages of not being influenced by the
turbidity or color of the samples and allowing the use of wider range of
samples, even cloudy ones, without pretreatment thereof.

[0008]Although this electrochemical biosensor is generally convenient when
used to monitor and control the amount of blood glucose, its accuracy is
greatly dependent on lot-to-lot variation between respective
mass-produced lots in which the biosensors are produced. In order to
eliminate such variation, most of the commercialized biosensors are
designed such that a user directly inputs calibration curve information,
which is predetermined at the factory, into a measuring device capable of
reading the biosensor. However, this method inconveniences the user a
great deal and causes the user to make input errors, thus leading to
inaccurate results.

[0009]In order to solve this problem, a method by which the resistance of
each electrode can be adjusted such that the variations in mass
production is corrected (US20060144704A1), a method in which a connection
to a resistor bank is made (WO2007011569A2), and a method by which
information is read by varying resistance through the adjustment of the
length or the thickness of each electrode (US20050279647A1) have been
proposed. The methods proposed for the electrochemical biosensors are all
based on a technique in which electrical variation is read. Furthermore,
a method for distinguishing production lot information by reading the
resistivity of a conductor marked on a strip using an electrical method
(U.S. Pat. No. 4,714,874) has been proposed.

[0010]However, these methods function to accurately adjust resistance, and
require a process of mass-producing the sensors first, measuring the
statistical characteristics of the sensors, and post-processing the
measured information again using a method of adjusting the resistance
marked on the sensors. However, the process of accurately adjusting the
resistance, marked in large quantities, through the post-processing is
very inconvenient, and is difficult to use in practical applications.

[0011]Methods in which colored marks are used with a spectral system
capable of discriminating colors to realize a colorimetric method (U.S.
Pat. No. 3,907,503, U.S. Pat. No. 5,597,532, U.S. Pat. No. 6,168,957),
and a method capable of reading bar codes (EP00075223B1, WO02088739A1)
have been proposed. These methods using color or bar codes are favorable
for a calorimetric method-based sensor using the spectrum system, but
they have technical and economic difficulties when applied to a system
using an electrochemical measurement mechanism. For example, the size and
structure of the area where the electrochemical sensor strip is inserted
into the measuring device for the purpose of electrical connection, that
is, the connection space of the sensor strip, is very limited when
constructing a device and circuit for spectroscopically identifying a
structure into which the production lot information is input, which
results in a great increase in system construction expense.

[0012]Furthermore, instead of the methods of marking the production lot
information on the sensor strip, a method of recording information on a
container or pack containing a sensor and allowing the information to be
read by the measuring device has been proposed. However, this method also
has a possibility of causing the user to make an error.

[0013]For conventional methods developed in order for users to measure the
blood glucose levels thereof using disposable electrochemical biosensor
strips without the need to manually input accurate calibration curve
information about biosensors, which differs from one production lot to
another into a measuring device, the sensors require a long period of
time for the preparation thereof, and also require post-processing, in
which errors are likely to be made.

[0014]Also, conventional devices for reading hue marks using a filter or a
monochromator for the wavelength of a light source encounter great
spatial limitations and pose problems in the construction of small-sized
systems.

[0015]Thus, there is a need for a biosensor that has a mark which is
simple and can be easily marked within a short time period, such as hue
marks, which are convenient to print on a small area of a biosensor, or
hole marks, which can be easily prepared simultaneously when the final
press process for mass production is performed, thereby allowing the
biosensor to be produced on a mass scale. Also, there is a need for a
biosensor that has production lot information recorded on the mark
through which the production lot information can be thus inputted to an
insulation plate of the biosensor, so that when the biosensor is inserted
into a measuring device, the production lot information is automatically
identified without a mistake being made by a user, thus enabling blood
glucose to be conveniently and accurately measured and being economical.

[0016]Leading to the present invention, intensive and thorough research
into electrochemical biosensors, conducted by the present inventors,
aiming to maintain economic efficiency in the construction of the
measuring device in which the production lot information thereof can be
easily and accurately input into the measuring device and which removes
the risk of mistakes being made by the user, thus providing an accurate
measurement value, resulted in the finding that, when the production lot
information is recorded in the form of hue marks or hole marks on the
electrochemical biosensor strip, and when various connectors are
connected with a small-sized emitter-detector system to automatically
read the production lot information, there is no need for a user to
manually input the production lot information of a biosensor, and thus
accurate measurement values can be conveniently obtained.

DISCLOSURE OF INVENTION

Technical Problem

[0017]Accordingly, the present invention has been made keeping in mind the
above problems occurring in the prior art, and an object of the present
invention is to provide an electrochemical biosensor measuring device
which automatically identifies the production lot information of the
biosensor without a mistake being made by a user upon the insertion of an
electrochemical biosensor into a measuring device, thus enabling blood
glucose to be conveniently and accurately measured.

Technical Solution

[0018]In order to accomplish the above object, the present invention
provides an electrochemical biosensor measuring device, which measures an
electrochemical biosensor composed of plurality of electrodes including
at least a working electrode and an auxiliary electrode prepared on at
least one or two insulating plates; a capillary sample cell for
introducing a sample into the electrodes; a reaction reagent layer,
formed on the working electrode, containing a redox enzyme and an
electron transfer mediator; an electrical connection portion for
connecting the working electrode and the auxiliary electrode; and a
production lot information identification portion configured such that
production lot information is recorded on at least one insulating plate,
which is selected from among at least two planar insulating plates and
does not interrupt a connection between the electrodes,

[0019]wherein the electrochemical biosensor measuring device comprises a
connector having a structure in which at least one light absorption or
reflection path sequentially comprising a light emitter-production lot
information identification portion-detector unit is acquired to thus
identify the production lot information recorded in the biosensor.

[0020]In the specification, the term "biosensor" is used to have the same
meaning as the term "biosensor strip".

ADVANTAGEOUS EFFECTS

[0021]The electrochemical biosensor measuring device according to the
present invention automatically identifies the production lot information
of the biosensor without a mistake being made by a user upon the
insertion of an electrochemical biosensor into a measuring device, thus
enabling blood glucose to be conveniently and accurately measured.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022]The above and other objects, features and advantages of the present
invention will be more clearly understood from the following detailed
description taken in conjunction with the accompanying drawings, in
which:

[0023]FIG. 1 is a schematic perspective view of a connector having a
transparent body installed in a measuring device in accordance with an
embodiment of the present invention;

[0024]FIG. 2 is a schematic perspective view of a connector provided with
a transmission window in one side thereof, which is used in a measuring
device in accordance with an embodiment of the present invention;

[0025]FIG. 3 is a schematic perspective view of a connector constructed to
have a sliding structure, which is used in a measuring device in
accordance with an embodiment of the present invention;

[0026]FIG. 4 is a schematic perspective view of a connector comprising a
light emitter, a detector and an electrical connection portion in an
integrated structure therein, which is used in a measuring device in
accordance with an embodiment of the present invention;

[0027]FIG. 5 is a schematic perspective view of a connector comprising a
light emitter, a detector system and an electrical connection portion in
an integrated structure therein, which is used in a measuring device in
accordance with an embodiment of the present invention;

[0028]FIG. 6 is a schematic perspective view of a connector comprising an
image signal identification device and an electrical connection portion
in an integrated structure, which is used in a measuring device in
accordance with an embodiment of the present invention;

[0029]FIG. 7 is a schematic sectional view showing the insertion of a
biosensor to a connector in a measuring device according to an embodiment
of the present invention; and

[0030]FIG. 8 is a flow chart showing a measuring process using a biosensor
measuring device in accordance with the present invention.

[0043]The electrodes of the electrochemical biosensor used in the
electrochemical biosensor measuring device according to the present
invention may be formed on one or both of at least two planar insulating
plates. That is, (1) a single working electrode and a single auxiliary
electrode (or reference electrode) may be formed on the same planar
insulating plate, or (2) may be formed on two planar insulating plates
facing each other [parallel electrodes; reference: E. K. Bauman et al.,
Analytical Chemistry, vol 37, p 1378, 1965; K. B. Oldham in
"Microelectrodes: Theory and Applications," Kluwer Academic Publishers,
1991; J. F. Cassidy et al., Analyst, vol 118, p 415].

[0044]In addition, the electrodes of the electrochemical biosensor used in
the electrochemical biosensor measuring device according to the present
invention may further include a sample fluidity determining electrode,
which is disposed behind the working electrode and is capable of
measuring the fluidity of whole blood samples on a lower planar
insulating plate.

[0045]The biosensor is described in greater detail taking parallel
electrodes as an example.

[0046]In the case where the electrochemical biosensor used for the
electrochemical biosensor measuring device according to the present
invention is constructed using the parallel electrodes, the biosensor may
have a structure in which the working electrode and the auxiliary
electrode are spaced apart from each other by a pressure-adhesive spacer
which is 50-250 μm thick, and are aligned or not aligned with each
other and facing each other.

[0047]In the thin spacer, a capillary sample cell on the microliter volume
scale is provided for injecting a bio-sample in a measurement space
defined by the working electrode and the auxiliary electrode and
retaining the sample therein. The capillary sample cell includes a sample
introducing portion and a micro-path.

[0048]In the thin spacer, a sample fluidity determining electrode is
placed preferably at a predetermined distance from the working electrode
or the auxiliary electrode so that fluorinated blood having a corpuscle
volume of 40% can reach the working electrode (or the auxiliary
electrode) along a micro-path 0.5-2 mm wide and 50-250 μm high within
about 600 ms, and more preferably at a predetermined distance from the
working electrode or the auxiliary electrode such that non-fluorinated
blood can reach the electrode along the micro-path 0.5-2 mm wide and
50-250 μm high within 300 ms, and still more preferably within 200 ms.

[0049]Functioning to introduce a blood sample into one end of the
biosensor, the sample-introducing portion is preferably formed in a "L"
shape so as to allow the rapid, accurate and convenient introduction of a
blood sample from the fore end of the biosensor strip. The sample
introducing portion is structured such that an allowance space is formed
the a location at which a sample introducing path and an air vent cross
each other. By the term "cross", as used herein, it is meant that the
sample-introducing path and the air vent are not arranged parallel to
each other, but intersect each other at a predetermined point. During
measurement, the allowance space helps maintain a constant and accurate
volume of the blood sample within the path while discharging the excess
sample through the air vent. Also, the allowance space may be used as the
place where the sample fluidity determining electrode is disposed. When
introduced into the sample introducing portion, a blood sample moves to
the electrodes through the micro-path.

[0050]In the electrochemical biosensor used in the electrochemical
biosensor measuring device according to the present invention, the
reaction reagent layer may be formed merely by applying a reagent
solution only to the working electrode, or to both the working electrode
and the sample fluidity determining electrode. The reaction reagent layer
includes an enzyme, such as a glucose oxidase or a lactate oxidase, an
electron transfer mediator, a water-soluble polymer, such as a cellulose
acetate, a polyvinyl alcohol or a polypyrrol, a fatty acid having 4 to 20
carbon atoms as a reagent for reducing a hematocrit effect, and a
hydrophilic quaternary ammonium salt.

[0051]In the electrochemical biosensor according to the present invention,
electrode connection portions at which the biosensor and the measuring
device are electrically connected are designed to exist in the same plane
in which the working electrode and auxiliary electrode are connected via
connection lines. The level of blood glucose that is measured by the
biosensor of the present invention from the results of an electrochemical
reaction is provided to the measuring device through the electrode
connection portions, and thus can be numerically converted into a precise
blood glucose value.

[0052]The electrochemical biosensor according to the present invention
includes a production lot information identification portion 500 for
providing calibration curve information about various concentrations of
liquid samples, which is used for respective production lots at the time
of manufacturing the biosensor, along with biosensor production lot
information, to a user.

[0053]The production lot information identification portion 500 may
include at least one mark selected from the group consisting of hue
marks, hole marks, and light-transmitting film-covered hole marks.

[0054]In the electrochemical biosensor measuring device according to the
present invention, the production lot information encoded by the hue
mark, the hole mark or the light-transmitting film-covered hole mark can
be identified using various methods including an optical method, an
imaging method, and an IR beam method. The operational principle by which
the production lot information identification portion in the measuring
device is identified is described in detail below.

[0055]In the measuring device, at least two light emitters, for examples,
photodiodes, are integrated within a small space. Photodiodes useful in
the present invention are preferably three-component light emitting
diodes emitting red, blue and green colors, or four-component light
emitting diodes emitting white, red, blue and blue colors, but are not
limited thereto. The light emitter may use an infrared light source.
Using the light emitted from the photodiodes or the infrared light
source, the information encoded by the hue mark, the hole mark or the
light-transmitting film-covered hole mark marked in the production lot
information identification portion of the biosensor is detected.

[0056]The hue mark may display the information about differences between
production lots according to differences in color, brightness, or chroma.
The hole mark may encode the information about differences between
production lots as a combination of close and open holes. As for the
light-transmitting film-covered hole mark, its information about
differences between production lots can be indicated by varying the
degree of transmission of the film covering the hole mark. It is
preferred that the number of hue marks or hole marks be adjusted to fall
within the range of 1 to 10.

[0057]The light sensed by the production lot information identification
portion is transmitted therethrough or reflected therefrom, and
experiences a change in intensity or wavelength. The transmitted or
reflected light is detected by a detector 703, such as an optical
identifier, placed at a location between the light emitters 702. The
change in the intensity and wavelength of light, as detected by the
detector 703, is delivered to a calculation system (not shown) from which
the change appears as the production lot information of the biosensor.

[0058]The light emitter 702 and the detector 703 may be constructed in a
separated or integrated structure. The detector 703 may be located in the
same plane as the light emitter 702 when it is adapted to detect the
light reflected from the hue marks, the hole marks or the
light-transmitting film-covered hole marks, and may be located in a plane
opposite the light emitter 702 when it is adapted to detect the
transmitted light. With regard to the hue marks, the differences in the
image made by their combinations correspond to differences in the
information about production lots. The images of the marks are detected
by an image signal identification device 707, such as a CCD camera, and
are transmitted to a calculation system (not shown) from which the image
signal appears as the production lot information of the biosensor.

[0059]The production lot information identification portion 500, adapted
for the electrochemical biosensor, which is used for the electrochemical
biosensor measuring device according to the present invention, is not
limited to a parallel type electrochemical biosensor, and may also be
applied to a plane type electrochemical biosensor, which is implemented
such that the working electrode and the auxiliary electrode are formed in
the same plate and are thus operated, and to a differential type
electrochemical biosensor, which is implemented such that the parallel
type electrochemical biosensor and the plane type electrochemical
biosensor process signals differently.

[0060]A connector used in the electrochemical biosensor measuring device
according to the present invention preferably has a structure in which
one or more absorption or reflection path(s) comprising a light
emitter-production lot information identification portion-detector can be
realized, thereby identifying the production lot information marked on
the biosensor.

[0061]As shown in FIG. 1, the connector 700, for example, may be formed of
a body made of transparent material, such as transparent acrylic or
plastic.

[0062]Furthermore, the connector 700, as shown in FIG. 2, may be provided
with a transmission window 706 in one side thereof so that infrared rays
absorbed or reflected via the light emitter-production lot information
identification portion-detector 700 are passed therethrough. Accordingly,
even when the connector is made of opaque material, or even when the body
of the connector is colored, the light beams radiated by the light
emitters 702 can easily reach the production lot information
identification portion of the biosensor through the transmission window
706, and thus the production lot information can be identified.

[0063]Furthermore, in order to pass the light beams, which are absorbed or
reflected via the light emitter-production lot information identification
portion-detector, through the connector 700, the connector 700 may be
manufactured such that one side thereof has a sliding door structure
700b. In greater detail, when a biosensor is inserted into the connector,
the sliding door structure 700b of the connector is pushed along with the
biosensor in the insertion direction of the biosensor, thus realizing the
path along which the light beams can reach the production lot information
identification portion of the biosensor. In this case, the sliding door
structure 700b may be connected to a device that can passively or
automatically remove the biosensor, and thus the biosensor can be easily
separated and removed from the biosensor measuring device using the
removing device (not shown) after the use of the biosensor.

[0064]As shown in FIGS. 4 to 6, the connector may comprise the light
emitters 702, the detector 703 and electrical connection portions 705 in
an integrated structure within the body thereof. For example, the
connector of FIG. 4 employs a three-color diode as a light emitter 702
and an optical identifier as a detector in an integrate structure, by
which differences in the color, brightness or chroma of the production
lot information identification portion of the biosensor are detected to
thus identify the production lot information. The connector of FIG. 5
employs an infrared light source 703 as a light emitter 702 and an
optical identifier as a detector 703 in an integrated structure in order
to discriminate the differences in the color, brightness or chroma of the
production lot information identification portion of the biosensor,
thereby identifying production lot information. FIG. 6 shows a connector
700 which employs an image signal identification device 707 as a detector
by which the image encoded by the hue mark of the production lot
information identification portion is detected so as to identify the
production lot information. Preferably, the image signal identification
device may be a charge coupled device (CCD) camera.

[0065]It may be generally difficult or uneconomical to construct a system
in which a hue or hole mark identification circuit of a photospectrometer
system is installed in combination with a circuit and device for
measuring the biosensor of an electrochemical system. With the recent
development of small-sized light emitting device, detecting device and
circuit design technologies, however, a system, the constitution of which
was considered unfeasible in the past due to incompatibility between
constitutional components, can be easily and economically implemented in
a small circuit space at minimal cost.

[0066]Conventional devices for reading hue marks using a filter or a
monochromator to determine the wavelength of a light source encounter
great spatial limitations and pose problems in the construction of
small-sized systems. In the recognition of production lot information, in
contrast, the biosensor according to the present invention can readily
identify hue marks and allows the construction of an economical system
because it uses small-sized three-component light emitting diodes
emitting red, blue and green colors at the same time and detects overall
variation in the light reflected from or transmitted through the hue
marks with a small-sized optical identification device. The advantage of
such electrochemical measurement is combined with the advantages of
recent small-sized spectral device technologies obtained by the
development of technology, and thus a biosensor that is economical and
provides precise measurement values can be provided.

[0068]inserting a biosensor provided with a production lot identification
portion containing production lot information into the connector port of
the biosensor measuring device to activate its power (step 1);

[0069]identifying the production lot information of the biosensor inserted
at Step 1 (step 2);

[0070]activating measurement and operation processes of the biosensor
measuring device in conformity with the production lot information
identified at Step 2 (step 3); and

[0071]introducing a liquid sample to the sample inlet of the biosensor to
result in quantitative electrochemical information about the sample,
quantifying a specific component of the liquid sample, and displaying
quantification results (step 4).

[0072]The measuring method using the biosensor measuring device of the
present invention is described stepwise in detail below.

[0073]In step 1, a biosensor provided with a production lot identification
portion containing production lot information into the connector port of
the biosensor measuring device is inserted to activate its power.

[0074]As shown in FIG. 7, the biosensor is inserted into the connector 700
of the measuring device through a sensor injection hole. Upon insertion,
the electrodes 104 of the biosensor 110 are electrically connected to the
electrical connection portions 705 of the connector to allow electric
current to flow, therefore operating the measuring device.

[0075]Next, Step 2 serves to identify the production lot information of
the biosensor which is inserted at step 1.

[0076]As shown in FIG. 7, the insertion of the biosensor 110 into the
connector 700 electrically connects the biosensor to the measuring device
through the connector 700 to activate the light emitter 702-detector 703
system in the measuring device, thereby identifying the production lot
information of the biosensor using the activated light emitter
702-detector 703 system.

[0077]In this regard, the identification of the production lot information
is implemented by the recognition of at least one mark selected from the
group comprising a hue mark, a hole mark and a light-transmitting
film-covered hole mark.

[0078]The hue mark may display the information about differences between
production lots by differences in the color, brightness, or chroma of a
plurality of color images. The hole mark may encode the information about
differences between production lots in the form of a combination of holes
which are independently open or closed. As for the light-transmitting
film-covered hole mark, its information about differences between
production lots can be displayed by varying the degree of transmission of
films covering open holes. It is preferred that the number of hue marks
or hole marks be adjusted to fall within the range of 1 to 10.

[0079]The identification of the production lot information can be achieved
as follows.

[0080]For instance, light beams are emitted sequentially from
three-component photodiodes of red, green and blue colors or
four-component photodiodes of white, red, green and blue colors to detect
the hue marks, hole marks or light-transmitting film-covered hole marks
of the production lot information identification portion. Variations in
wavelength, color, brightness and chroma depending on the degrees of
reflection or transmission of detected light beams are detected by an
optical identification device, so that the production lot information of
the biosensor can be identified.

[0081]In another example, image signals are detected from the hue marks of
the production lot information identification portion, thereby
identifying the production lot information of the biosensor.

[0082]In Step 3, measurement and operation processes of the biosensor
measuring device are activated in conformity with the production lot
information identified at Step 2.

[0083]Following the identification of the production lot information at
Step 2, in greater detail, the measuring device has measurement and
operation processes activated in conformity with the identified
production lot information, and enters a standby state for sample
measurement.

[0084]Finally, Step 4 serves to introduce a liquid sample to the sample
inlet of the biosensor to result in quantitative electrochemical
information about the sample, quantify a specific component of the liquid
sample, and display the quantified results.

[0085]In greater detail, the introduction of a liquid sample into the
biosensor strip inserted into the measuring device (step a) creates a
predetermined potential difference between the working electrode and the
auxiliary electrode and between the sample fluidity determining electrode
and the auxiliary electrode (step b), the sample flowing into the sample
introducing portion of the strip causes primary electrical variation
between the working electrode and the auxiliary electrode to adjust the
voltages between the electrodes to the same value (step c). The sample
fluidity determining electrode senses the flow of the sample to cause
secondary electrical variation, and the voltage between the auxiliary
electrode and the sample fluidity determining electrode is adjusted to be
the same, thus providing information about the time difference with the
electrical variation primarily sensed by the working electrode (step d).
When a liquid sample is sufficiently mixed with a reagent applied to the
working electrode, voltage is applied again between the working electrode
and the auxiliary electrode to cause a cyclic reaction in a parallel-type
thin layer electrochemical cell, and the stationary current value thus
reached is read (step e). The amount of the substrate present in the
sample is analyzed using the time information obtained in step d and the
stationary current value obtained in step e to determine the level of a
specific component, such as blood glucose, and the result is displayed in
a window.

[0086]As described hitherto, the electrochemical biosensor measuring
device according to the present invention automatically identifies the
production lot information of the biosensor without a mistake being made
by a user upon the insertion of an electrochemical biosensor into a
measuring device, thus enabling blood glucose to be conveniently and
accurately measured.

[0087]Although the preferred embodiments of the present invention have
been disclosed for illustrative purposes, those skilled in the art will
appreciate that various modifications, additions and substitutions are
possible, without departing from the scope and spirit of the invention as
disclosed in the accompanying claims.